Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers

Phase 1CompletedNCT03317717

Medy-Tox25 enrolled

Overview

This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

MeditoxinDRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

BotoxDRUG

injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male adults aged between 20 and 45 * Satisfying baseline nerve conduction criteria in below at screening visit CMAP M-wave amplitude of EDB ≥ 4.0mV CMAP M-wave amplitude of AH ≥ 5.0mV CMAP M-wave amplitude of ADQ ≥ 5.0mV Exclusion Criteria: * Have history of childhood botulism * Have a pacemaker or any other heart device * Have peripheral neuropathy or accessary peroneal nerve * Have history of lower limb myotomy or denervation surgery

Locations (1)

The Catholic University of Korea, St. Paul's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle

percentage reduction of CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle from baseline

Time frame: day 14, 30, 60, 90

Data from ClinicalTrials.gov

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